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Strategies for dealing with hemolyzed samples in regulated LC-MS/MS bioanalysis
Daniel Tang1, Elizabeth Thomas
1ICON Development Solutions, 5/F Standard Chartered Tower, 201 Shiji Avenue, Pudong, Shanghai, 200120, China. daniel.tang@iconplc.com
Bioanalysis
|December 6, 2012
Summary
Assessing hemolysis during bioanalytical method development and sample analysis is crucial. This approach helps identify and manage matrix effects in hemolyzed samples, ensuring data accuracy and reportability.
Area of Science:
- Bioanalytical Chemistry
- Pharmacokinetics
- Drug Development
Background:
- Industry consensus highlights the need to assess hemolysis impact on bioanalytical methods.
- Challenges exist in preparing standardized hemolyzed quality control (QC) samples and drawing conclusions during method validation.
Purpose of the Study:
- To propose an alternative strategy for hemolysis assessment during bioanalytical method development and sample analysis.
- To ensure the accuracy and reportability of bioanalytical data from hemolyzed samples.
Main Methods:
- Conducting hemolysis assessments during method development and sample analysis.
- Utilizing stable-labeled internal standards to detect potential matrix effects in hemolyzed samples.
- Employing dilution or standard addition to confirm data accuracy when abnormal internal standard responses occur.
- Recommending incurred sample reanalysis for hemolyzed samples to ensure method reproducibility.
Main Results:
- The proposed method allows for the identification of hemolyzed samples with potential matrix effects.
- Dilution or standard addition can validate data accuracy in affected samples.
- Incurred sample reanalysis confirms the robustness of hemolysis-insensitive methods.
Conclusions:
- Assessing hemolysis during method development and sample analysis is a practical approach to manage matrix effects.
- The proposed strategy ensures the reliability and reportability of bioanalytical data, especially for regulated studies.
- Documentation of hemolysis tests according to Good Laboratory Practice (GLP) requirements is essential for regulated studies.
